Efficacy and safety of Lutikizumab in study participants with moderate to severe ulcerative colitis
Summary description of the study
Ulcerative colitis (UC) is one of the inflammatory bowel diseases and causes inflammation and bleeding in the mucosa of the rectum and colon. The aim of this study is to assess the safety and efficacy of Lutikizumab in adult patients with UC and to compare Lutikizumab and Adalimumab in the treatment of UC. Furthermore, adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational drug being developed for the treatment of UC. Participants will be divided into groups called treatment arms. Each group will receive a different treatment. In the induction period, participants will be randomized and assigned to one of the 3 arms, where they will receive Lutikizumab dose 1, Lutikizumab dose 2, or Adalimumab. In the maintenance period, participants who have responded to Lutikizumab will be randomized and assigned to one of the 2 arms with a specific Lutikizumab maintenance therapy. Participants who have responded to Adalimumab will continue to receive Adalimumab. All participants who do not achieve a clinical response according to the modified Mayo score at the end of the induction period will receive unmasked Lutikizumab. Approximately 200 adults with UC will be enrolled at about 280 trial centers worldwide.
(BASEC)
Intervention under investigation
In the 12-week induction period, randomized participants will receive Lutikizumab as an infusion and then as a subcutaneous injection or Adalimumab as a subcutaneous injection.
At week 12, participants receiving Lutikizumab and responding to treatment will be randomized again and receive Lutikizumab as a subcutaneous injection at different intervals until week 52 (maintenance period). Participants receiving Adalimumab and responding to treatment will continue to receive Adalimumab as a subcutaneous injection until week 52. Participants who do not respond to treatment will receive unmasked Lutikizumab as a subcutaneous injection until week 52.
(BASEC)
Disease under investigation
Ulcerative colitis
(BASEC)
- Diagnosis of ulcerative colitis (UC) established at least 90 days prior to study start: appropriate documentation of biopsy results must be available. The results must be deemed by the investigator to be consistent with the UC diagnosis - Active UC with a modified Mayo score of 5–9 points and an endoscopic Mayo subscore of 2–3 (confirmed by a central review) - Documented inadequate response or loss of response to or intolerance to at least one of the following medications: aminosalicylates (tablets), corticosteroids, immunomodulators, and/or novel therapies (BASEC)
Exclusion criteria
- Current diagnosis of Crohn's disease or an unclassified inflammatory bowel disease - Extent of inflammatory disease is limited to the rectum (assessed by the endoscopy performed during screening) - Previous exposure to Adalimumab (including biosimilars). Note: The patient may also be enrolled if they have previously received other novel therapies including TNF blockers; only Adalimumab is excluded. (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
AbbVie Inc., USA AbbVie AG, CH
(BASEC)
Contact
Contact Person Switzerland
Franzisca Rusca
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie Medical Information
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
12.07.2024
(BASEC)
ICTRP Trial ID
NCT06257875 (ICTRP)
Official title (approved by ethics committee)
A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis (BASEC)
Academic title
A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (ICTRP)
Public title
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis (ICTRP)
Disease under investigation
Ulcerative Colitis (ICTRP)
Intervention under investigation
Drug: Lutikizumab Matching PlaceboDrug: Lutikizumab Matching PlaceboDrug: Adalimumab Matching PlaceboDrug: LutikizumabDrug: LutikizumabDrug: Adalimumab (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Participant has had a diagnosis of Ulcerative Colitis (UC) for at least 90 days
prior to Baseline. Appropriate documentation of biopsy results consistent with the
diagnosis of UC in the assessment of the investigator, must be available.
- Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic
Subscore (ESS) of 2 to 3 (confirmed by central review).
- Demonstrated inadequate response to, loss of response to, or intolerance to at least
one of the following: oral aminosalicylates, corticosteroids, immunomodulators,
and/or advanced therapies.
Exclusion Criteria:
- Current diagnosis of Crohn's Disease (CD) or inflammatory bowel
disease-unclassified.
- Extent of inflammatory disease limited to the rectum as assessed by screening
endoscopy.
- Prior inadequate response, intolerance or loss of response to adalimumab (including
biosimilars). Note: Participant may be enrolled if he/she discontinued adalimumab
for reasons other than those listed above (e.g., loss of insurance) or he/she has
been exposed to other advanced therapies, including anti-TNFs other than adalimumab. (ICTRP)
not available
Primary and secondary end points
Percentage of Participants who Achieve Endoscopic Improvement;Number of Participants with Adverse Events (AEs) (ICTRP)
Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS);Percentage of Participants who Achieve Clinical Response Per mMS;Percentage of Participants who Achieve Endoscopic Remission (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
ABBVIE INC.;ABBVIE CALL CENTER, abbvieclinicaltrials@abbvie.com, 844-663-3742, AbbVie, (ICTRP)
Secondary trial IDs
2023-505678-14-00, M23-703 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06257875 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available